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A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults

Sharma, H.; Hukins, D.; Barron, E.; Brealey, S.; Corbacho, B.; Costa, M. L.; Gedney, G.; Giotakis, N.; Hewitt, C.; Hugill-Jones, J.; Keding, A.; Flett, L.; McDaid, C.; Mitchell, A.; O'carroll, G.; Parker, A.; Scantlebury, A.; Stobbart, L.; Torgerson, D.; Turner, E.; Welch, C.; Adamson, J.; Flett, Lydia; Adamson, Joy; Barron, Elizabeth; Brealey, Stephen; Corbacho, Belen; Costa, Matthew; Gedney, Graham; Giotakis, Nikolaos; Hewitt, Catherine; Hugill-Jones, Jess; Hukins, Deborah; Keding, Ada; McDaid, Catriona; MItchell, Alex; Northgraves, M.; O Carroll, Grace; Parker, Adwoa; Scantlebury, Arabella; Stobbart, Lynne; Torgerson, David; Turner, Emma; Welch, Charlie; Sharma, Hemant

Authors

H. Sharma

D. Hukins

E. Barron

S. Brealey

B. Corbacho

M. L. Costa

G. Gedney

N. Giotakis

C. Hewitt

J. Hugill-Jones

A. Keding

L. Flett

C. McDaid

A. Mitchell

G. O'carroll

A. Parker

A. Scantlebury

L. Stobbart

D. Torgerson

E. Turner

C. Welch

J. Adamson

Lydia Flett

Joy Adamson

Elizabeth Barron

Stephen Brealey

Belen Corbacho

Matthew Costa

Graham Gedney

Nikolaos Giotakis

Catherine Hewitt

Jess Hugill-Jones

Deborah Hukins

Ada Keding

Catriona McDaid

Alex MItchell

Grace O Carroll

Adwoa Parker

Arabella Scantlebury

Lynne Stobbart

David Torgerson

Emma Turner

Charlie Welch

Hemant Sharma



Abstract

Aims A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures. Methods A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods. Discussion The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury.

Citation

Flett, L., Adamson, J., Barron, E., Brealey, S., Corbacho, B., Costa, M. L., …Sharma, H. (2021). A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults. Bone & Joint Open, 2(3), 150-163. https://doi.org/10.1302/2633-1462.23.BJO-2020-0178

Journal Article Type Article
Acceptance Date Dec 14, 2020
Online Publication Date Mar 5, 2021
Publication Date 2021-03
Deposit Date Mar 1, 2021
Publicly Available Date Jul 6, 2021
Journal Bone and Joint Open
Electronic ISSN 2633-1462
Publisher British Editorial Society of Bone and Joint Surgery
Peer Reviewed Peer Reviewed
Volume 2
Issue 3
Pages 150-163
DOI https://doi.org/10.1302/2633-1462.23.BJO-2020-0178
Keywords Trauma; Distal tibia; Orthopaedic surgery; Pilon fracture; Randomised controlled trial
Public URL https://hull-repository.worktribe.com/output/3710056

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Publisher Licence URL
https://creativecommons.org/licenses/by-nc-nd/4.0/

Copyright Statement
© 2021 Author(s) et al. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/





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